Brand Name | HF-RESECTION ELECTRODE "PLASMA-OVALBUTTON", OVAL BUTTON, 24 FR., 12°-30° |
Type of Device | HF-RESECTION ELECTRODES |
Manufacturer (Section D) |
OLYMPUS WINTER & IBE GMBH |
kuehnstrasse 61 |
hamburg 22045 |
GM 22045 |
|
Manufacturer (Section G) |
OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O. |
telickova 457/29 |
|
prerov |
|
Manufacturer Contact |
daniel
wladow
|
kuehnstrasse 61 |
hamburg 22045
|
GM
22045
|
4940669662
|
|
MDR Report Key | 13001091 |
MDR Text Key | 282208679 |
Report Number | 9610773-2021-00354 |
Device Sequence Number | 1 |
Product Code |
FAS
|
UDI-Device Identifier | 14042761083765 |
UDI-Public | 14042761083765 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K152092 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
01/12/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | WA22566S |
Device Catalogue Number | WA22566S |
Device Lot Number | 1000053216 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/01/2021
|
Initial Date FDA Received | 12/14/2021 |
Supplement Dates Manufacturer Received | 01/04/2022
|
Supplement Dates FDA Received | 01/12/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/08/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | OLMPUS OUTER SHEATH, 26 FR., 2 STOPCOCKS (A22026A); OLMYPUS INNER SHEATH (A22040T); OLYMPUS HF-CABLE, BIPOLAR (WA00014A); OLYMPUS TELESCOPE "OES ELITE", 4 MM (WA2T430A); OLYMPUS WORKING ELEMENT, PASSIVE (WA22367A); OLYMPUSHF-GENERATOR ESG-400 (WB91051J) |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 70 YR |
Patient Sex | Male |
|
|